Course Description

Co-sponsored by IPEC-Americasand The Center for Professional Advancement (CfPA); partners in training and education (T&E).

Excipients often play a critical role in the manufacture of biopharmaceuticals and in the formulation of small molecule and biopharmaceutical products as well as, enabling delivery of medicines to the patients who need them. Companies that manufacture, distribute and use excipients must meet appropriate quality and regulatory requirements. The General Notices of the United States Pharmacopeia-National Formulary (USP-NF), states: “Official substances are prepared according to recognized principles of good manufacturing practice and from ingredients complying with specifications designed to ensure that the resultant substances meet the requirements of the compendial monographs.”

Compliance with compendial requirements is a legal and regulatory requirement in those countries in which a pharmacopoeia is specified. While there is good awareness of compendial requirements for drug products and APIs, there is less understanding by excipient manufacturers related to confirmation the excipient meets the pharmacopoeia monograph.

This comprehensive 2-day course includes an introduction to the pharmacopoeias, with an emphasis on the USP-NF and Ph. Eur. A global perspective which touches on other pharmacopeias is presented. Details of the content, organization and use of the pharmacopoeias are covered, along with regulatory considerations for excipients. The course reviews practical examples of compliance with compendial requirements, as published by pharmacopoeias. In addition, there is exploration of the development and revision processes for compendial monographs with real-life case studies, along with a review of efforts toward compendial harmonization by IPEC, the Pharmacopoeial Discussion Group (PDG), and the International Conference on Harmonisation (ICH). The course concludes with an exploration of approaches to compendial surveillance, opporrtunities for advocacy, and ultimately, compliance with the requirements in the pharmacopoeias.

The course will assist the global bio/pharmaceutical industry; including innovator, generic, biotechnology, Contract Manufacturer, and consumer-care companies, seeking greater understanding of compliance requirements for excipient suppliers, particularly with the USP-NF and Ph. Eur.